FDA Adverse Event
Malfunction
Summary report: N
CENTURION VISION SYSTEM
MDR report key: 3870080
·
Received April 29, 2014
Report
- Report Number
- 2028159-2014-00583
- Event Type
- Malfunction
- Date Received
- April 29, 2014
- Date of Event
- April 1, 2014
- Report Date
- April 1, 2014
- Manufacturer
- ALCON - IRVINE TECHNOLOGY CENTER
- Product Code
- HQC
- PMA / PMN Number
- K121555
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADD'L REPORTABLE INFO BECOMES AVAILABLE. (B)(4).
Description of Event or Problem · 1
A SURGEON REPORTED A SYSTEM MESSAGE (SM) WAS DISPLAYED DURING THE CORTEX REMOVAL PHASE OF A CATARACT WITH INTRAOCULAR LENS IMPLANT PROCEDURE. AFTER THE SM NO IRRIGATION OR ASPIRATION WAS AVAILABLE. THE FLUID MANAGEMENT SYSTEM (FMS) WAS REMOVED, REINSERTED AND THE SYSTEM REPRIMED. THE CASE WAS COMPLETED WITH NO PATIENT HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 256582 | CENTURION VISION SYSTEM | PHACOFRAGMENTATION SYSTEM | HQC | ALCON - IRVINE TECHNOLOGY CENTER | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |